Events

Retiro De Equipo (Recall) de Halyard Closed Suction Kits with Flex Connector

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Halyard Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00232-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-04-24
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00232-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Halyard australia has been made aware of overseas reports indicating certain flex connectors supplied with 'halyard closed suction with flex connector' devices may become loose or disconnect before use or during use. if disconnection occurs during use, it will result in an open respiratory circuit and interruption of patient ventilation.To date, there have been no reports of permanent patient injury as a result of this issue. no reports of disconnect have been received from australian facilities to date.
  • Acción
    Halyard is advising: - Before using the Flex Connector, evaluate its connection to the Swivel Connector of the Closed Suction adapter to ensure an adequate connection. Evaluation of the connection can be accomplished by pushing the Flex Connector onto the Swivel Connector. Users should refer to the images provided on the Customer Letter to establish whether an adequate connection has been obtained. - If a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector and ensure adequate connection

Device

Halyard Closed Suction Kits with Flex Connector
  • Modelo / Serial
    Halyard Closed Suction Kits with Flex Connector Multiple Product TypesARTG Number: 259994(Halyard Australia - Catheter, suction, general-purpose)
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Halyard Australia Pty Ltd

Manufacturer

Halyard Australia Pty Ltd